Pfizer is retreating from China's biosimilar market, ending development of three programs and selling a biologics plant pegged to make them to WuXi Biologics. In addition to the Pfizer deal, the Chinese CDMO also penned a deal to buy a more than 90% stake in another local CDMO play, CMAB Biopharma. Japanese company Fujifilm has chosen Holly Springs, North Carolina, as the location for its planned $2 billion cell culture facility. And more.
Pfizer has decided to halt its three biosimilar programs in China and sell a biologics facility there to CDMO giant WuXi Biologics after a “comprehensive review of the biosimilars market and the company’s global manufacturing network,” the U.S. pharma said. Pfizer poured $350 million into establishing the facility in 2016 and planned to make copies of Roche cancer meds Avastin and Herceptin, plus a biosim of AbbVie’s immunology med Humira. But the market is becoming too crowded.
The Pfizer deal gives WuXi Biologics facilities covering 50,000 square meter in Hangzhou, China, with drug substance and drug product capacities for vial filling and prefilled syringes. Meanwhile, the CDMO also signed another purchase agreement this week with investment firm CBC Group and other companies for a more than 90% stake in CMAB Biopharma Group, a local CDMO based in Suzhou, China. It gives WuXi Bio 7,000-liter drug substance capacity and drug product capacity for liquid and lyophilization.
Fujifilm previously laid out a $2 billion plan to establish the biopharma CDMO world’s largest cell culture facility in North America. Now, it has chosen Holly Springs, North Carolina, as the location for the project. Expected to be operational by the spring of 2025, the site will feature eight 20,000-liter bioreactors and room to expand to 24 bioreactors. It expects to employ 725 people by the end of 2028.
Eisai has a known interest in Alzheimer’s disease, with an existing partnership with Biogen featuring closely watched aducanumab. The Japanese pharma has signed a new research collaboration with the German Center for Neurodegenerative Diseases to discover novel treatments for neurodegenerative disorders including Alzheimer’s.
Scientists at the University of Hong Kong (HKU), in collaboration with the Sanford Burnham Prebys Medical Discovery Institute, pointed to old leprosy drug clofazimine as a promising, low-cost COVID-19 antiviral after recording positive results in hamsters. HKU has launched a phase 2 study testing the combination of the med with interferon beta for hospitalized COVID-19 patients, and a monotherapy phase 2 is planned for the outpatient setting.
Takeda has manufacturing capacity earmarked at Germany’s IDT Biologika for its upcoming dengue vaccine, TAK-003. Because that shot hasn’t reached the U.S. FDA for evaluation, the Japanese pharma is lending that capacity temporarily to Johnson & Johnson for making its single-shot COVID-19 vaccine. IDT said it will handle filling and packaging of the vaccine.
The FDA cited China’s Foshan Biours Biosicences, which specializes in over-the-counter gel patches. In a warning letter, the agency blasts the company’s plant in Foshan, China, for failing to adequately test finished products and follow equipment cleaning procedures, among other shortfalls.